Keytruda demonstrated superior recurrence-free survival in patients with resected high-risk stage II melanoma.

At the first interim analysis, Keytruda reduced the risk of disease recurrence or death by 35% (HR=0.65 [95% CI, 0.46–0.92]; p=0.00658) compared to placebo. Median RFS had not been reached for either group at the time of this analysis. After 14.4 months follow-up, 11.1% (n=54/487) of patients on Keytruda had recurrence or died compared with 16.8% (n=82/489) of patients on placebo, with fewer distant recurrences with Keytruda (4.7%, n=23/487) versus placebo (7.8%, n=38/489).

“We conducted KEYNOTE-716 to explore whether adjuvant Keytruda, an approved adjuvant treatment option across all resected stage III melanoma, could prolong recurrence-free survival for patients with resected high-risk stage II disease,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “These findings of a significant 35% reduction in the risk of disease recurrence or death compared to placebo support earlier intervention with KEYTRUDA. We are pleased that these findings have been accepted for priority review by the FDA, and we are grateful to the investigators and patients for their involvement in this important study.”

The safety profile of Keytruda was consistent with previously reported studies in patients with solid tumors. Treatment-related adverse events (TRAEs) occurred in 79.9.% of patients who received Keytruda versus 60.9% of patients who received placebo, while Grade 3 or 4 TRAEs were observed in 16.1% versus 4.3% of patients, respectively.

“Patients diagnosed with stage IIB and IIC melanoma have a high risk of recurrence after complete resection and similar five-year survival outcomes as those with stage IIIA and IIIB disease, but because there are no systemic treatment options available, the standard of care is observation,” said Dr. Jason Luke, director, Cancer Immunotherapeutics Center at UPMC Hillman Cancer Center. “The encouraging results from KEYNOTE-716 show that adjuvant treatment with pembrolizumab was associated with a significant reduction in disease recurrence or death versus placebo for patients with resected high-risk stage II melanoma and, if approved, may offer these patients a new treatment option.”

These late-breaking data from KEYNOTE-716 are being presented at the European Society for Medical Oncology (ESMO) Congress 2021 (Abstract #LBA3) and are being featured as part of the official ESMO press program.

Finding cancer at an earlier stage may give patients a greater chance of long-term survival. Many cancers are considered most treatable and potentially curable in their earliest stage of disease. Building on the strong understanding of the role of Keytruda in later stage cancers, Merck is studying Keytruda in earlier disease states, with approximately 20 registrational studies ongoing across multiple types of cancer.